Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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24 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Cleanrooms B ecause contamination is a serious issue in cleanroom op- erations, controlling contamination generated by human operators and their clothing is a major concern (1). People disperse large numbers of particles (i.e., skin fragments, bac- teria, hair) that vary in number from person to person and over time. Thus, cleanroom garments must be designed to protect the environment and the process by containing the particles generated by the person while not becoming a source of contamination. The garment system must therefore be able to manage the particulate, and, in some cases, the microbial risk to the product and process, according to Anne Marie Dixon-Heathman, principal, Cleanroom Management Associates. An important decision that faces the manager of any cleanroom is the selection of a cleanroom garment or garment system, according to Dixon-Heathman. Following up on a presentation given by Dixon- Heathman at INTERPHEX 2021 on in-use testing of garments, Phar- maceutical Technology spoke to Dixon-Heathman for further insight. In-use test protocol PharmTech: What are some of the reasons you decided to investigate an 'in-use' testing protocol Dixon-Heathman (Cleanroom Management Associates): People shed, and solv- ing contamination issues in today's cleanrooms is challenging. In 2015, I published a chapter on 'Investigations for Personnel Monitoring' in the book Microbial Risk and Investigations (2). In this chapter, I performed testing of particle generation from people inside a cleanroom during operations. This testing in an ISO 5 class cleanroom showed the excessive In-Use Testing of Cleanroom Garments Feliza Mirasol Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control. WARUT - STOCK.ADOBE.COM

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